Drug License2018-12-06T06:07:22+00:00

Drug License

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Drug License (Retail/Whoesale) Registration

Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However a particular business entity may require different types of drug license based on their business, you may contact LegalRaasta for consultancy on it.

In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific. If drugs are sold or stocked for sale at more than one place,application shall be made, and license shall be issued, in respect of each such place except migrant vendors.

Once the licence is granted to the business, all such License must ensure that all the condition in the drug licence are complied at all the time during the course of the business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities and authorities shall be kept informed for all the changes or modification in the business activities.

Drug License Registration is done through LegalRaasta.

What is Included in Our Package

Procedure for Drug License Registration

Documents required to obtain Drug License

Following documents are required with application form :

  • Constitution of the firm (MOA/AOA)
  • Photo ID proof of proprietor/partner/director
  • Copy of Property paper (If owned property)
  • Copy of Rent agreement (If rented property)
  • Site Plan and key plan of the premises
  • Refrigerator invoice and details
  • Affidavit regarding compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)

Additional document for Retail Sale Registered Pharmacist

  • Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
  • Registration of Delhi Pharmacy Council
  • Appointment Letter and Bio-data

Additional document for Wholesale Licence Competent person

  • Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
  • Experience Certificate
  • Appointment Letter and Bio-data

Conditions for obtaining Drug License

The applicant has to provide an independent shop with the adequate area for grant of retail/wholesale licences as per details given below :

For grant of a licence in Form 20 or Form 21 or both, the premises are of an area of not less than 10 square metres.

For grant of a licence in form 20-B or form 21-B or both, the premises are of an area of not less than 10 square metres.

For grant of licences :

  • In Form 20 or Form 21 or both,
  • In Form 20-B or Form 21-B or both, the premises should be of an area of not less than 15 square metres.
  • The clear height of the sales premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.

No drug licence is granted in a premises situated on a DDA alloted residential plot/land or flat unless it meets with the requirements of MPD-2021.

Types of Drug License

Drug licence is classified under different categories. These are Manufacturing Licence, Sale Licence and Loan licence. Sale licence is further classified as wholesale Licence, Retail Licence and Restricted (Gen.Store) licence depending on the manner in which sales done.

Steps for getting the Drug license

One can file the Drug License application directly with the government. The process is long and requires 30-60 days to get completed :

Step 1 :

Applicant has to obtain user ID and Password by giving request letter in person with the details of the firm.

Step 2 :

All the documents should be scanned in 100 dpi and black and white and then should be uploaded using the said ID and Password at space provided for the purpose. All the information is filled precisely for respective application and then e-send the application. The licensing authority may ask for any other specific documents if required.

Step 3 :

You will then need to follow-up with the government department for an update on your application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited by the government.

Step 4 :

The government department will take 45-60 working days to completely review your application and approve the same. Else, you can hire LegalRaasta for getting the Drug license for you. We get license issued in 98% of our cases and save our customers from all the government hassles.

Frequently Asked Questions

1. What are the esssential requisites to obtain a Sales Drug Licence (Retail) for the Chemist Shop?
The applicant’s shop / premises should have an adequate area of not less than 10 sqr.mtrs., should be equipped with proper storage facilities for preserving the properties of drugs and applicant (Competent Person) must be a Registered pharmacist with Pharmacy Council.
2. What are the essential requisites for obtaining Sales Drugs Licences(Wholesale)?
The applicant’s shop/premises should have an adequate area of not less than 10 sqr.mtrs. and person in charge (Competent Person) must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year’s experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.
3. What are the essential requisites for obtaining retail cum wholesale licences?
The applicant’s shop / premises should have an adequate area of not less than 15 sqr. mtrs.
4. Where to file a complaint about quality of Drugs and other violations?
Written complaint about doubtful quality of Drugs can be made to the Drugs Control Department, Govt. of N.C.T. of Delhi, at F-17, Karkardooma, Shahdara, Delhi-32 indicating name and address of the complainant,name and other particulars of the Drug under complaint and nature of complaint.
5. How to obtain more information about the Drug licenses and related provisions?
Various provisions dealing with Drug licenses are given under Drugs & Cosmetics Act, 1940 & rules there under. Information can also be sought in person from the drug inspectors seated in Drugs Control Department.

Testimonials

What our Customers say?

I have used multiple offline & online CAs/ Lawyers. LegalRaasta clearly provided the best service and fast.

Nitin Batra

CEO, CaterWow Pvt. Ltd.

Their team helped me protect my brand with trademark registration. The service was swift and delivered at half the cost.

Shilpa Khatana

Co-founder, Skillofy.com

I will highly recommend LegalRaasta for startups given its quality support and speed. And all this comes at a economical price.

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Founder, Shiksha Learning Academy

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